Global Specialty Generics Market Size, Share & Industry Trends Analysis Report

Global Specialty Generics Market Size, Share & Industry Trends Analysis Report By Type (Injectables, Oral Drugs, and Others), By Application, By End Use (Specialty Pharmacy, Retail Pharmacy, and Hospital Pharmacy), By Regional Outlook and Forecast, 2023 - 2030

The Global Specialty Generics Market size is expected to reach $141.5 billion by 2030, rising at a market growth of 9.8% CAGR during the forecast period.

Oncology is one of the major application specialty generics, thereby, it generated $10,292 million revenue in the market in 2022. Cancer will be the primary cause of nearly 10 million deaths in 2020, or close to one in every six. About 30% of cancer cases in low- and lower-middle-income nations are caused by cancer-causing diseases such as the human papillomavirus (HPV) and hepatitis. Many cancers are curable if caught early and treated successfully, but due to the adoption of a Western lifestyle, heavy alcohol and tobacco use, bad dietary habits, and lack of physical activity. The market is expected to see increased demand as cancer cases rise.

The major strategies followed by the market participants are Product Launches as the key developmental strategy to keep pace with the changing demands of end users. For instance, In January, 2023, Sun Pharmaceutical Industries rolled out the generic version of palbociclib, a breast cancer medication by Pfizer. The launch would be under the brand name Paleno, which would address the treatment requirements of several advanced breast cancer patients in India. Additionally, In July, 2022, Dr Reddy's Laboratories announced the launch of the generic version Bortezomib for Injection, the medication of Velcade brand. The product launch can be used for the treatment of certain types of cancer across the US market. The product can be delivered in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous.

Based on the Analysis presented in the KBV Cardinal matrix; Novartis AG are the forerunners in the Market. In September, 2020, Novartis collaborated with the African Union through the Africa Medical Supplies Platform. This collaboration would enhance the supply of medicines from the Novartis Pandemic Response offering to the AU member states and Caricom countries. Companies such as Viatris, Inc., Dr. Reddy’s Laboratories Ltd., Teva Pharmaceuticals Industries Ltd., Fresenius SE & Co. KGaA and Hikma Pharmaceuticals PLC are some of the key innovators in the Market.

Market Growth Factors

Growing ageing population.

The WHO reports that people are living longer overall. The majority of people today likely plan to live until their sixties and beyond. By 2030, one in six people will be 60 years of age or older. 1.4 billion people will be above the age of 60 by this time, up from 1 billion in 2020. By 2050, there will be 2.1 billion people in the globe who are 60 years of age or older. According to projections, there will be 426 million individuals who are 80 years of age or older by the year 2050. By 2050, low- and middle-income countries will be home to two-thirds of the world's over-60 population. The need for specialty generics will rise as people live longer and endure more severe problems like chronic illnesses and cancer.

Growing healthcare expenditures

The increasing number & size of investments invested in the healthcare industry by governments of different nations is one of the primary drivers of the market's growth. The WHO reports that healthcare spending reached a record high of US $9 trillion (about 11% of global GDP) due to substantial increases in healthcare spending by governments at all income levels. In general, rising government health spending largely offsets declining personal spending. Increasing spending in the healthcare industry has led to an increase in market innovations. The market is expanding as a result of increased investment in the healthcare industry.

Market Restraining Factors

Regulatory challenges impeding market growth

Due to their complexity or distinctive delivery methods, specialty generics may need more regulatory attention. These items may require expensive and time-consuming regulatory approval. Market entrance delays and regulatory obstacles can prevent the market from expanding. Specialty generics might not cleanly fit into current legislative or approval processes. In order to handle these complicated items, regulatory bodies may need to modify their regulations or create new procedures. This might delay the launch of specialty generics by making the approval process take longer and creating more uncertainty for producers.

Type Outlook

On the basis of type, the market is classified into injectables, oral drugs and others. In 2022, the injectables segment dominated the market with the maximum revenue share. The segment's growth can be ascribed to the advantages of injectables, such as their quick absorption and long-lasting effects, which increase patient compliance and acceptability. Drug therapies known as specialty injectable generics are available as generics and are utilized to treat chronic conditions that must be administered via infusion, injection, or inhalation. It has the same active ingredients as the branded versions of it and includes biologics that are used to treat various medications.

Application Outlook

Based on application, the market is segmented into oncology, inflammatory conditions, multiple sclerosis, hepatitis C, and others. The hepatitis C segment recorded a remarkable revenue share in the in 2022. Most hepatitis C infections result from exposure to blood from risky injection techniques, unscreened blood transfusions, risky medical procedures, injecting drugs, and sexual behaviors that expose one to blood. Around 1.5 million new cases of the hepatitis C virus are reported each year, with an estimated 58 million people worldwide carrying the infection. According to estimates, 3.2 million children and adolescents worldwide have chronic hepatitis C infection.

End use Outlook

By end use, the market is fragmented into specialty pharmacy, retail pharmacy, and hospital pharmacy. In 2022, the specialty pharmacy segment witnessed the largest revenue share in the market. Because specialty pharmacies have low distribution costs and convenient access to medications, major specialty generic manufacturers & insurance companies choose them for product distribution. In addition, in comparison to branded products, specialty generic drug inventory's low cost offers a better return on investment. Maximizing patient access, timely delivery, and efficient distribution management of specialty pharmacies all draw consumers to them and thus contribute to the expansion of this market segment.

Regional Outlook

Region wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. In 2022, the North American region led the market by generating the highest revenue share in the market. This is due to the existence of regulatory policies that are favorable to the approval of innovative products. The American FDA has launched several attempts to streamline the entire approval procedure. Therefore, the major producers continuously work to commercialize specialty generic medicines on the market.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Teva Pharmaceuticals Industries Ltd., Novartis AG, Hikma Pharmaceuticals PLC, Sun Pharmaceutical Industries Ltd., Fresenius SE & Co. KGaA, Dr. Reddy’s Laboratories Ltd., Mallinckrodt PLC, Bausch Health Companies, Inc., Viatris, Inc. and Apotex, Inc.

Recent Strategies Deployed in Specialty Generics Market

Partnerships, Collaborations and Agreements:

Mar-2022: Viatris Inc. partnered with Kindeva Drug Delivery L.P., a developer and manufacturer of products across a wide range of complex drug-delivery formats. Under this partnership, both companies received FDA approval for Breyna, the generic version of AstraZeneca's Symbicort. The Bryna is a drug-device combined product that is indicated for various patients with asthma or chronic obstructive pulmonary disease and would be available in 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths.

Sep-2021: Hikma Pharmaceuticals PLC signed an agreement with FAES Farma S.A., a manufacturer, and developer of commercialized pharmaceutical products. Under this agreement, both companies would aim to market and sell Bilastine tablets which is a non-sedating second-generation antihistamine molecule for the treatment of allergic rhinitis and urticaria.

Product Launches and Product Expansions:

Jan-2023: Sun Pharmaceutical Industries rolled out the generic version of palbociclib, a breast cancer medication by Pfizer. The launch would be under the brand name Paleno, which would address the treatment requirements of several advanced breast cancer patients in India.

Jan-2023: Hikma Pharmaceuticals PLC released an authorized generic version of Jazz Pharmaceuticals’ Xyrem oral solution, a prescription medicine for narcolepsy symptoms in people of 7 years or older. This launch broadens Hikma's diversified offering of generic products and emphasizes its capability to reach millions of people relying on Hikma's medicines.

Jan-2023: Hikma Pharmaceuticals PLC rolled out the Naloxone Hydrochloride Injection, USP, 2mg/2mL, in the prefilled syringe (PFS) form across the US. This would be the third PFS product launch that can be used for the emergency treatment of a known or expected opioid overdose.

Jul-2022: Dr Reddy's Laboratories announced the launch of the generic version Bortezomib for Injection, the medication of Velcade brand. The product launch can be used for the treatment of certain types of cancer across the US market. The product can be delivered in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous.

Mar-2022: Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. introduced a generic version of Revlimid1, the medication in 5mg, 10mg, 15mg, and 25mg strengths across the United States. The launched product aims to deliver patients with another key treatment alternative for highly challenging conditions, indicating Teva's adherence to making complex generic drugs accessible to patients who require a generic version of Revlimid.

May-2021: Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd., unveiled the generic version of THIOLA tablets, the medication for use in combination with high fluid intake, alkali, and diet modification. The launched generic version is unresponsive to treatment with alkali, high fluid intake, and diet modification.

Acquisitions and Mergers:

Mar-2022: Fresenius completed the acquisition of mAbxience, a leading international biopharmaceutical company. The acquisition aimed at expanding its business by making cheaper versions of biotechnology drugs that have lost patent protection. Also, the acquisition would further strengthen and leverage Fresenius Kabi's position, as both perfectly complement the company's growth businesses in biopharmaceuticals & medical technology.

Approvals and Trials:

Sep-2022: Bausch Health Companies Inc. came into partnership with Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals Ltd. Through this partnership, both companies would unveil RYALTRIS which received approval from Health Canada for the symptomatic treatment of moderate to critical seasonal allergic rhinitis and associated ocular symptoms in children aged 6 years and more.

Scope of the Study

Market Segments covered in the Report:

By Type

• Injectables
• Oral Drugs
• Others

By Application

• Inflammatory conditions
• Multiple sclerosis
• Hepatitis C
• Oncology
• Others

By End Use

• Specialty Pharmacy
• Retail Pharmacy
• Hospital Pharmacy

By Geography

• North America
• US
• Canada
• Mexico
• Rest of North America
• Europe
• Germany
• UK
• France
• Russia
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• South Korea
• Singapore
• Malaysia
• Rest of Asia Pacific
• LAMEA
• Brazil
• Argentina
• UAE
• Saudi Arabia
• South Africa
• Nigeria
• Rest of LAMEA

Companies Profiled

• Teva Pharmaceuticals Industries Ltd.
• Novartis AG
• Hikma Pharmaceuticals PLC
• Sun Pharmaceutical Industries Ltd.
• Fresenius SE & Co. KGaA
• Dr. Reddy’s Laboratories Ltd.
• Mallinckrodt PLC
• Bausch Health Companies, Inc.
• Viatris, Inc.
• Apotex, Inc.

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